A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia. - Full Text View

Sponsors and Collaborators:	PICS, Inc. National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	PICS, Inc.
ClinicalTrials.gov Identifier:	NCT00310284

Purpose

The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.

Condition	Intervention
Insomnia	Behavioral: Computerized delivery of cognitive-behavioral treatment of insomnia Behavioral: Self-help manual to improve insomnia symptoms

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Computerized Self-Help Treatment for Primary Insomnia

Further study details as provided by PICS, Inc.:

Primary Outcome Measures:

Changes in sleep parameters via polysomnography
Changes in sleep parameters via self-reported sleep diary
Changes in symptom severity as measured by Insomnia Severity Index
Changes in symptom severity as measured by Pittsburgh Sleep Quality Index
Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory

Secondary Outcome Measures:

Changes in depression symptoms as measured by Beck Depression Inventory II
Changes in quality of life as measured by a qualitative instrument
Usability of the device as measured by a qualitative questionnaire

Estimated Enrollment:	200
Study Start Date:	January 2006

Detailed Description:

Chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. The condition is associated with daytime fatigue, lack of concentration, and decreased quality of life. Most people with chronic primary insomnia go untreated, because of a desire to avoid medication or lack of access to quality non-drug treatments. Therefore, an affordable, easy to use, and effective computer to help assess and treat insomnia symptoms could bring treatment to this population.

Comparison: We are comparing a new handheld computer that uses cognitive-behavioral treatment principles to a popular self-help manual for the treatment of primary insomnia symptoms.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

sleep less than 6.5 hours per night
at least 30 minutes of sleep onset latency or wakefulness after sleep onset
symptoms present for at least 6 months
must have insomnia symptoms at least 3 days per week

Exclusion Criteria:

Body Mass Index greater than 32
Presence of anxiety disorder
Secondary forms of insomnia
Presence of a substance use disorder
Concurrent treatment for another mental disorder
History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310284

Contacts

Contact: Anahi Collado-Rodriguez, B.S.

703-766-2849

acollado@lifesign.com

Locations

United States, Virginia
PICS, Inc.	Recruiting
Reston, Virginia, United States, 20191
Contact: Anahi Collado-Rodriguez, B.S. 703-766-2849 acollado@lifesign.com
Principal Investigator: Bradford W. Applegate, Ph.D.

Sponsors and Collaborators

PICS, Inc.

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Bradford W Applegate, Ph.D.

PICS, Inc.

More Information

No publications provided

Study ID Numbers:	5-R44-HL-65893, 5-R44-HL-65893
Study First Received:	March 31, 2006
Last Updated:	March 31, 2006
ClinicalTrials.gov Identifier:	NCT00310284 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by PICS, Inc.:

Insomnia
Sleep

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on May 07, 2009